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Sarizotan HC1 in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia

This study has been completed.
Sponsor:
Information provided by:
EMD Serono
ClinicalTrials.gov Identifier:
NCT00105508
First received: March 15, 2005
Last updated: November 4, 2010
Last verified: November 2010
History of Changes
  Purpose

The purpose of this study is to determine if Sarizotan HC1 1 mg b.i.d. (taken twice a day) is effective in the treatment of dyskinesia associated with dopaminergic treatment of Parkinson's disease (PD).


Condition Intervention Phase
Parkinson's Disease
Dyskinesia
 Drug: Sarizotan HC1
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled, Multicenter, Multinational Phase III Study to Evaluate the Safety and Efficacy of Sarizotan HCl 1 mg b.i.d. in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by EMD Serono:

Estimated Enrollment: 600
Study Start Date: September 2004
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The subject is an out-patient.
  • The subject presents with a diagnosis of idiopathic Parkinson's disease.
  • Prior therapy with all registered Parkinsonian medication is allowed.

Exclusion Criteria:

  • (For female subjects) The subject is pregnant or lactating.
  • The subject is participating in another clinical study or has done so within the past 30 days.
  • The subject has received neurosurgical intervention related to PD.
  • The subject has relevant renal impairment.
  • The subject has relevant hepatic impairment.
  • The subject is suffering from any dementia or psychiatric illness.
  • The subject has a history of allergic asthma.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00105508

  Show 31 Study Locations
Sponsors and Collaborators
EMD Serono
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00105508     History of Changes
Other Study ID Numbers: EMR 62225-018
Study First Received: March 15, 2005
Last Updated: November 4, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by EMD Serono:
Parkinson's Disease
Dyskinesia
Dyskinesia associated with dopaminergic treatment

Additional relevant MeSH terms:
Dyskinesias
Parkinson Disease
Stress, Psychological
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
 Signs and Symptoms
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Neurodegenerative Diseases
Behavioral Symptoms

ClinicalTrials.gov processed this record on June 18, 2013